510(k) K072929 ยท JXG Shunt, Central Nervous System And Components
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Dec 7, 2007 |
| Received | Oct 16, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072929
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2019 | Integra LifeSciences Corp. LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML
LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML
LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML
LimiTorr INS9030SP1 I Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.